Extended indication Senshio is indicated for the treatment of moderate to severe symptomatic vulvar and vaginal atrophy
Therapeutic value No estimate possible yet
Registration phase Positive CHMP opinion

Product

Active substance Ospemifene
Domain Metabolism and Endocrinology
Reason of inclusion New medicine (specialité)
Main indication Other metabolism and Endocrinology
Extended indication Senshio is indicated for the treatment of moderate to severe symptomatic vulvar and vaginal atrophy (VVA) in post-menopausal women
Proprietary name Senshio
Manufacturer Shionogi
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Extramural (GVS)
Additional comments The active substance in Senshio, ospemifene, is a selective oestrogen receptor modulator (SERM). This means that it acts in the same way as oestrogen in some tissues in the body such as the vagina and so helps to reduce symptoms of vulvovaginal atrophy.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date June 2021
Expected Registration June 2022
Orphan drug No
Registration phase Positive CHMP opinion
Additional comments Positieve CHMP opinie ontvangen in januari 2022.

Therapeutic value

Current treatment options Vaginaal oestrogeen (estriol of estradiol).
Therapeutic value No estimate possible yet
Frequency of administration 1 times a day
Dosage per administration 60 mg
References NCT01586364; NCT00276094; NCT00276094

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

Cost 605.00
References NHS Commissioning Statement
Additional comments De jaarlijkse kosten in het Verenigd Konikrijk zijn door de NHS berekend als £514.68 per jaar. Omgerekend zou dit €604,58 per patiënt per jaar betekenen.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.